AlphaNine SD Coagulation Factor IX (Human) has been approved for the prevention and control of bleeding in subjects with Factor IX deficiency due to hemophilia B.
The efficacy of AlphaNine SD has been evaluated in clinical trials involving 13 surgical subjects. Control of bleeding was judged to be excellent. Another study found that AlphaNine SD did not lead to the formation of prothrombin in the bloodstream. This means that AlphaNine is less likely to cause unwanted blood clots (thrombosis) than Factor IX Complex preparations. These contain larger amounts of other proteins such as Factors II, VII and X. Thrombosis can be a serious problem with the use of certain Factor IX concentrates.
Side effects included headache, fever, chills, flushing, nausea, and vomiting. In rare cases, subjects may have an allergic reaction to AlphaNine SD. Signs of an allergic reaction are hives, rash, tightness of the chest, wheezing, low blood pressure and difficulty in breathing. If such a reaction happens, infusion should be stopped at once.
Hemophilia B, also called Christmas Disease, affects one in 25,000 males. Mild forms of the condition can also affect female carriers. People with hemophilia B suffer from a deficiency in the Factor IX protein, necessary in blood clotting. The condition is characterized by prolonged bleeding, especially into joints and soft tissues.